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Home/Research/Esketamine/Schizophrenia

Esketamine for Schizophrenia

8 papers and 2 clinical trials exploring esketamine as a treatment for schizophrenia.

Compounddissociative

Esketamine

Esketamine (Spravato) is the S-enantiomer of ketamine, approved as an intranasal treatment for treatment-resistant depression and MDD with acute suicidal ideation. It is administered under clinical supervision with post-dose monitoring and has reached over $1.6 billion in annual sales.

Full Esketamine profile
IndicationApproximately 24 million people worldwide are affected by schizophrenia.

Schizophrenia

Schizophrenia is a complex psychiatric disorder characterised by disruptions in thought processes and perception. Recent research into psychedelics has opened new avenues for understanding its neurobiology and exploring potential therapeutic mechanisms, particularly in addressing treatment-resistant symptoms.

Full Schizophrenia profile

Academic Research

8 papers
Open Accessindividual

Esketamine Monotherapy in Adults With Treatment-Resistant Depression: A Randomized Clinical Trial

In a phase 4, multicentre, double-blind randomised trial in adults with treatment‑resistant depression, intranasal esketamine monotherapy (56 mg and 84 mg) produced significant reductions in MADRS score versus placebo at day 28 (LS mean differences −5.1 and −6.8; effect sizes 0.48 and 0.63) and demonstrated rapid benefit at 24 hours. The tolerability profile was consistent with prior reports, most commonly nausea, dissociation, dizziness and headache.

Published
September 1, 2025
Journal
JAMA Psychiatry
Authors
Janik, A., Qiu, X., Lane, R., Popova, V., Drevets, W. C., Canuso, C. M., Macaluso, M., Mattingly, G. W., Shelton, R. C., Zajecka, J. M., Fu, D. J.
Open Accessmeta

Cost-per-remitter for esketamine nasal spray versus quetiapine for treatment-resistant depression

Using ESCAPE-TRD trial data in an Excel-based model, esketamine nasal spray plus an oral antidepressant achieved a 50% remission rate at 32 weeks versus 33% for quetiapine XR plus an oral antidepressant. The model estimated lower cost-per-remitter for esketamine (about $3,102 lower in a commercial setting and $456 lower in Medicaid), suggesting esketamine plus an oral antidepressant is cost‑effective for adults with treatment‑resistant depression.

Published
June 9, 2025
Journal
Journal of Comparative Effectiveness Research
Authors
Clemens, K., Teeple, A., Rive, B., Kirson, N., Desai, U., Doran, J., Eid, D., Qu, A., Bowrey, H., Joshi, K.
Open Accessindividual

Esketamine Nasal Spray vs Quetiapine Extended-Release: Examining Work Productivity Loss and Related Costs in Patients With Treatment-Resistant Depression

This secondary analysis (n=321) of the ESCAPE-TRD trial compared work productivity loss (WPL) and related costs in patients with treatment-resistant depression (TRD) receiving esketamine nasal spray (56mg or 84mg) versus quetiapine (atypical antipsychotic) extended release, both combined with an oral antidepressant. By week 8, WPL decreased by 30.3% with esketamine and 17.3% with quetiapine, leading to a cost savings difference of $156 per week. By week 32, WPL reductions were 45.3% (esketamine) and 32.5% (quetiapine), with a weekly cost savings difference of $153.

Published
January 27, 2025
Journal
Journal of Clinical Psychiatry
Authors
Clemens, K., Pmhnp-Bc, A., Teeple, D., Zhdanava, M., Shah, A., Joshi, K., Buyze, J., Pilon, D., Bowrey, H. E., Godinov, Y.
Paywallindividual

Esketamine nasal spray versus quetiapine XR in adults with treatment-resistant depression: a secondary analysis of the ESCAPE-TRD randomized clinical trial

In a secondary analysis of ESCAPE-TRD (n=636), esketamine nasal spray plus an oral antidepressant, dosed according to US prescribing information, produced significantly higher remission rates from week 8 to week 32 and greater, earlier reductions in MADRS scores (from day 8) than quetiapine XR, with fewer discontinuations due to adverse events.

Published
January 17, 2025
Journal
CNS Spectrums
Authors
McIntyre, R. S., Mattingly, G., Godinov, Y., Buyze, J., Turkoz, I., Cabrera, P., Patel, M., Martinez, L., Himedan, M., Lopena, O.
Open Accessindividual

Efficacy of esketamine nasal spray over quetiapine extended release over the short and long term: sensitivity analyses of ESCAPE-TRD, a randomised phase IIIb clinical trial

Sensitivity analyses of the randomised ESCAPE‑TRD trial confirmed that adjunctive esketamine nasal spray was consistently superior to quetiapine extended release for achieving remission at Week 8 and remaining relapse‑free to Week 32 (relative risks 1.46–1.84, all p<0.05). Esketamine also shortened time to first and confirmed remission (hazard ratios ≈1.66–1.71), supporting the robustness of the original findings.

Published
December 2, 2024
Journal
British Journal of Psychiatry
Authors
Young, A. H., Llorca, P. M., Fagiolini, A., Falkai, P., Cardoner, N., Nielsen, R. E., Blomqvist, O., Godinov, Y., Rive, B., Diels, J., Mulhern-Haughey, S., Reif, A.
Paywallindividual

Esketamine Nasal Spray versus Quetiapine for Treatment-Resistant Depression

This open-label Phase IIIb trial (n=676) compared the efficacy of esketamine nasal spray and extended-release quetiapine, combined with an SSRI or SNRI, in patients with treatment-resistant depression (TRD). The study found that a significantly higher percentage of patients in the esketamine group achieved remission at week 8 (27.1% vs 17.6%) and had no relapse through week 32 after remission at week 8 (21.7% vs 14.1%). Adverse events were consistent with the established safety profiles of the trial treatments.

Published
October 5, 2023
Journal
New England Journal of Medicine
Authors
Reif, A., Bitter, I., Buyze, J., Cebulla, K., Frey, R., Ito, T., Kambarov, Y., Llorca, P-M., Oliveira-Maia, A. J., Messer, T., Mulhern-Haughey, S., Fu, D. J.

Clinical Trials

2 trials
RecruitingPhase III

Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure (INTENSIFY)

This randomized, controlled trial (n=1254) investigates the effect of an intensified pharmacological treatment (including ketamine/esketamine and clozapine) for schizophrenia, major depressive disorder (MDD), and bipolar depression in subjects who experienced a first-time treatment failure on their first-line treatment.

Started
March 31, 2024
Type
interventional
Blinding
single
Randomized
Yes
Registry ID
NCT05603104
CompletedPhase III

Ketamine for the treatment of depressive and negative symptoms in patients with schizophrenia: a randomized controlled cross-over pilot study

Randomised, double-blind, crossover Phase III pilot (n=20) comparing IV esketamine (Ketanest S) versus active placebo (diphenhydramine) for negative and depressive symptoms in patients with schizophrenia-spectrum disorders.

Started
September 7, 2021
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
2019-004489-16

Explore further

Search all Esketamine papers Search all Schizophrenia trials Full Esketamine profile Full Schizophrenia profile